Reviews the documents as to compliance with the requirements and submits report
Release approved LTO
Start
Assess the documents as to completeness and verified against the e-copy
Prepares the License to Operate (LTO)
Initial and recommends approval of the LTO
DocumentsComplete and the same as e-copy
N
Y
Submits Application At BHDT
Reviews the application and assigns task of technical evaluation and inspection
Requirements Complied?
Approves the LTO
End
Disapproved Application and return to applicant
A
Y
N
For Inspection?
N
Y B
C
VII. FLOWCHART LICENSE TO OPERATEMedical Device Establishment
ResponsiblePerson
Turnaround(per day)
TimeRequired
To do the Job
Applicant
Evaluator
Evaluator
Evaluator
Evaluator
Division Chief
Division Chief
Director
Clerk
Day 1
Day 3
Day 8-15
Day 16-20
Max 30 min
15 minutes
Max 60 min
Max 30 min
15 minutes
15 minutes
Reviews the Evaluation Report Division Chief
Receives application and assigns control number
Evaluator
Day 2 - 6
Applicant pays at the Cashier and Return the Order of Payment at the BHDT
Prepares the Notice of Deficiency
Approves the Notice of Deficiency
Mail/Fax the Notice of Deficiency
End
A
Prepares Department Personnel Order
Conducts Inspection
Prepares and Submits Inspection Report
B
Requirements Complied?
DN
Reviews the Inspection Report
C
Y
ResponsiblePerson
Turnaround(per day)
Evaluator
Clerk
Division Chief
Division Chief and Director
Day 16-B
Day 73-80-B
Day 81-B
15 min
15 min
30 minutes
30 minutes
Clerk
Day 16-18-A 5 min
15 min
Inspector
Inspector
TimeRequired
To do the Job
Day 17-72-B 240 min
Submits Compliance to Deficiencies
Release approved LTO
Prepares the License to Operate(LTO)
Initial and recommends approval of the LTO
Requirements Complied?
End
A
Y
N
D
Turnaround(per day)
Inspector 15 min
15 minDivision Chief
TimeRequired
To do the Job
Applicant
Clerk
60 days complianceperiod
5 days
Approves the LTO Director